Clarinex/Claritin

[Guest guest]

Thought this article would be of interest to those using

antihistamines for flushing/urticaria:

http://www.washingtonpost.com/ac2/wp-dyn?

pagename=article&node=&contentId=A3957-2002Mar22&notFound=true

We're Not Gonna Take It

Contrary to Ads' Message, Clarinex is Not Better Than Its Predecessor

(C. Kelley - For The Washington Post)

By M. Otto

Special to The Washington Post

Tuesday, March 26, 2002; Page HE01

You may have seen those strange new television ads for Clarinex,

Schering-Plough's chip-off-the-old-blockbuster replacement for its

non-sedating antihistamine pill, Claritin.

Crowds mill on a grassy plain. Pan out as an enormous Clarinex pill

hurtles through the heavens toward Earth, a meteor of relief. Cut to

Clarinex particles capping histamine receptors in an animated blood

vessel. A voice tells us the drug is the only allergy pill that

delivers 24-hour relief from any allergy, anywhere, at any time.

In the background we hear " We're Not Gonna Take It " and other

snippets from " Tommy, " The Who's 1969 rock-opera about a deaf, dumb

and blind boy who takes a lot of new drugs on his way toward

salvation.

Schering-Plough has launched the blitz (with related magazine and

newspaper ads) to encourage Claritin users to switch to Clarinex

before rival drug makers introduce generic versions of the drug or

before Claritin goes over-the-counter, either of which may happen by

year's end. The company has even made Clarinex cheaper than Claritin,

to expedite the shift to the new drug. Claritin generated about $3.2

billion in sales worldwide for Schering-Plough last year, roughly one-

third of the company's total for pharmaceuticals.

The ads may have you thinking that Clarinex is more effective than

Claritin. But doctors interviewed for this story say this is not the

case.

" I wouldn't recommend it. It is not any better than Claritin, " said

Rudy Mueller, a family physician with 1,500 patients in his

town, N.Y., practice. Mueller is author of " As Sick as It Gets, "

a book about, among other topics, how drug makers influence medical

practice.

Mueller said there is no science to show that the new drug offers a

real advantage over the old one.

Jean Barbey, a physician who is interim director of the division of

clinical pharmacology at town University Medical Center,

agreed. The U.S. Food and Drug Administration (FDA) approved Clarinex

Dec. 21, based on studies that proved it worked better than a placebo

against allergies. But the tests did not compare the drug head-to-

head with Claritin. Without such studies, it's impossible to say

whether allergy patients will do better on Clarinex, Barbey said.

In Europe, where Clarinex has been on sale for months, the European

Agency for the Evaluation of Medicinal Products (EMEA) tried to make

up for that lack of direct comparison by studying trial results for

the two drugs. After reviewing studies involving thousands of

patients, EMEA, which clears drugs for sale in the European Union

countries, concluded that dose per dose, Clarinex is " probably not

superior " to Claritin.

British National Health Service pharmacists reached a similar

conclusion. " As the action, efficacy and side effects of [Clarinex]

are similar to [Claritin], there is no reason to prefer it over

products already available, " they said in a May 2001 report.

Proven Better Than Nothing

When asked if Clarinex is an improvement over Claritin, Schering-

Plough spokesman Bill O'Donnell answered a different question. He

noted that the new drug is the only pill approved to treat indoor

allergies -- hence the ads' tag about countering allergies that

arise " anywhere. "

O'Donnell said Schering-Plough had thought about getting Claritin

approved for indoor allergies, but figured the older drug did not

have what it needed to win FDA approval for that use.

Barbey, who at one time served as a consultant to Schering-Plough, is

not impressed by the indoor allergy claim. " It doesn't mean a lot to

me, " he said. " It's more a question of marketing strategy, " an

attempt to show some advantage over Claritin. " They probably just

tried harder " to get Clarinex approved for indoor use, he said.

O'Donnell refused to speculate whether the purported indoor allergy

advantage would hold up if Claritin and Clarinex were tested head-to-

head for that use.

Barbey said Clarinex does offer a theoretical advantage.

Most drugs are composed of two molecules, mirror images of each other

called stereoisomers, he explained. Schering-Plough isolated

Claritin's biologically active isomer and repackaged it as a new drug.

That's why patients who take 10 mg of Claritin can usually take 5 mg

of Clarinex, the recommended daily dose. The new drug is more potent.

That might be helpful for patients who found that Claritin didn't

work well for them.

But Claritin is converted to Clarinex in the body, which means that

most patients get just as much active drug with the 10 mg dose of

Claritin as they do with the 5 mg dose of Clarinex, Barbey said. So

the potency advantage is questionable.

" It's not a proven, practical advantage, " he said. " Will it translate

to a clinical advantage? Probably not. "

The Nexium Connection

-Norton, director of pharmacy services at the Everett

Clinic, a 185-physician group practice in Everett, Wash., suspects

that Schering-Plough never tested Clarinex against Claritin because

the company knew it could not demonstrate a clinically significant

difference between the drugs.

She thinks that bringing Clarinex to market was a " business decision "

that " had nothing to do with clinical care. We have looked at the

data and we see no difference between Claritin and Clarinex, so we

are not adding it to our formulary, " she said. " We are educating our

doctors that Clarinex offers no benefits. "

Schering-Plough declined to comment on its business decisions

regarding the product.

-Norton says she is worried about the effect of the Clarinex

ads on her clinic's patients. " As soon as ads hit, patients start

asking for the drug, " convinced that new means better, she said.

It reminds -Norton of another " new and improved " drug that came

out about a year ago and is now advertised constantly on TV -- Nexium.

Nexium is AstraZeneca's replacement for its legendarily lucrative

heartburn pill, Prilosec. In 2000, Prilosec was the best-selling drug

in the nation, with sales topping $4 billion. AstraZeneca is now

battling in court to keep generic versions off the market -- and

battling in the market to drive consumers to Nexium.

In Nexium ads, hopeful baby boomers stand on a rocky outcrop at

ocean's edge or in the desert looking to hear the good news about

the " new purple pill. " Nexium obligingly rains down from the heavens.

" I just had a patient come in who has been on Prilosec for years and

has been stable. His first question to me was, 'Should I be on

Nexium?' " said Mueller shortly after the ads started in June. " Of

course not. But try to tell that to a patient who just saw the TV ad.

It is pretty frustrating trying to reeducate patients after they see

these commercials. "

Nexium is based on the same principle as Clarinex. It is an isomer of

Prilosec, repackaged as a new drug.

Mueller and -Norton are skeptical of Nexium because they have

read the drug's label. In two FDA-reviewed studies, Nexium worked

consistently better than Prilosec only when it was used in a higher

dose. In a third study, however, a higher dose of Nexium did not work

any better than a lower dose of Prilosec. When the same amounts of

drug were used in a fourth study, there was no difference between

them.

The studies looked at how quickly the drugs healed erosive

esophagitis, a potentially serious condition in which stomach acid

eats away at the lining of the esophagus, and how well the drugs

prevented heartburn once esophagitis was healed.

The label notes that in three European trials for gastro-esophageal

reflux disease (GERD), which is a far more common cause of heartburn,

Nexium offered no significant advantage over Prilosec even when used

in higher doses.

One FDA reviewer concluded that although AstraZeneca proved Nexium

worked, it failed to demonstrate that it worked better than Prilosec.

Another suggested that patients who took equal amounts of either drug

would probably get the same results.

AstraZeneca spokesman Jim Coyne said there have been no additional

studies comparing Prilosec directly with Nexium.

Shortly after the Nexium ads hit, Doug Levine, a physician who is

chief medical officer of AstraZeneca's gastrointestinal therapeutic

area, explained that in the Nexium trials, Prilosec had, by chance,

worked better than it normally does. He also mentioned company-

generated data that showed Nexium suppresses acid better than

Prilosec. Patients taking Nexium therefore might not need over-the-

counter acid suppressors as much when they are on the drug, he said.

But -Norton has studied her clinic's patients and has not seen

any difference when they switch to Nexium. They need to use OTC

heartburn remedies and visit the doctor's office just as often, she

said.

Still, with the massive advertising push, AstraZeneca managed to

capture about 17 percent of new " proton pump inhibitor " heartburn

pill prescriptions in 2001, making it the most successful launch ever

in that class of drugs, according to the company's annual report,

which also noted that Prilosec has lost users to Nexium. With so many

patients already taking the new drug, the company will be in good

shape to retain its users when cheaper generic equivalents to

Prilosec hits the market in coming months.

When discussing Nexium, Levine said that patients who are doing fine

on Prilosec, or any other drug, should generally not, as a matter of

good clinical practice, switch to another medication to treat their

condition.

The Emperor's New Pills

Schering-Plough seems to be following the Nexium strategy, according

to pharmacist Lee Vermeulen, University of Wisconsin clinical

associate professor of pharmacy and director of the University of

Wisconsin Hospital and Clinics' Center for Drug Policy.

As AstraZeneca did with Nexium, Schering-Plough is offering free

trials of Clarinex, selling it at a discount compared with its

predecessor and flooding the airwaves with ads. Clarinex commercials

even employ the same subtly biblical, vaguely unsettling drugs-from-

heaven imagery as the Nexium ads.

O'Donnell said his company is " pleased with the launch, " but would

not comment on the number of Clarinex converts Schering-Plough has

won since the ad campaign started on March 4. He declined to discuss

the company's marketing strategy.

Vermeulen helps set drug policy for his university's 85,000-member

health plan. That means he spends a lot of his time comparing

pharmaceuticals. Drugs like Nexium and Clarinex get under his skin.

Both are perfect examples of what he calls the " stereoisomer

strategy. "

" The isomer is developed simply to extend the patent life of the

drug, " Vermeulen said. " The company then tries like crazy to find

something to differentiate the new agent from the parent, but the

clinical advantage is simply not there. No self-respecting physician

will be swayed by the propaganda that these companies are passing off

as relevant science. "

Because of that, companies turn to direct-to-consumer ads to whip up

consumer demand, he said. Consumers with no medical background make

easy targets and are quite willing to make the switch, at least as a

trial. " Once the patient has switched, it is very difficult to get

them to switch back to the generic version of the older product they

were very happy with in the past, " Vermeulen said, even if the new

drug doesn't work any better.

He says he would like to see the FDA refuse to approve drugs unless

drug companies show a clear benefit over products already on the

market. He says that could happen if the federal government gets into

the drug-buying business.

" I'd be surprised if we didn't see reform of this sort as the

Medicare prescription benefit becomes a reality, " he said. " We can't

afford this kind of nonsense from the industry. "

Bargain Pricing

Barbey agreed with AstraZeneca's Levine that it's generally a bad

idea for patients who are doing well on one drug to switch to

another. But given the similarity between Claritin and Clarinex, it

would be " perfectly reasonable, " Barbey said, to switch to Clarinex

to save a few dollars.

Schering-Plough is selling the drug at about a 17 percent discount to

Claritin, which makes it a bargain for the 50 percent or so of

allergy patients who find Claritin helpful. A CVS in the District

sells a 30-day supply of Clarinex for $79.59. A month's worth of

Claritin goes for $95.99.

When Claritin goes over-the-counter or becomes available generically

by its chemical name, loratadine, Barbey said, it would probably be

best to compare the new forms with Clarinex and choose the drug you

can get least expensively, balancing your insurance co-payment with

your out-of-pocket expenses.

-Norton noted that patients should try nasal steroid sprays,

like Schering-Plough's own Nasonex, before turning to non-sedating

antihistamines. Numerous studies have shown they work better, have

few side effects and generally cost less.

But only about 25 percent of patients give steroid sprays a try

before they are prescribed an antihistamine. This has something to do

with the fact that nasal sprays bother some people, -Norton

said, but she suspects that slick advertising has something to do

with it, too.

M. Otto is a physician assistant and medical reporter who

covers health law and medical research for BNA in Washington.

© 2002 The Washington Post Company